Container for receiving and separating a fluid, preferably blood plasma, into its ingredients

ABSTRACT

A container for receiving and separating blood plasma into its ingredients comprises two sealingly coupled sections (1 and 2). One container section (2) and the adjacent portion of the other container section are made of solid material, and the two container sections are screwed together. The container sections (1 and 2) comprise their respective chambers (29 and 30) for receiving their respective fluid ingredients, and these chambers are interconnected through a connecting channel (31) through the abutting portions, at which the container sections (1 and 2) are screwed together. A valve seat (21, 27) is shaped at each end of the connecting channel (31) for each valve member (22, 16) for a sealing closing of the chambers (29, 30) in the separated state of the container sections (1, 2). The valve members (22, 16) comprise mutually abutting projections (23, 12) ensuring a distance between the valve members (22, 16) exceeding the distance between the associated valve seats (27, 21) in the coupled state of the container sections (1, 2), but being smaller than the distance between the associated valve seats (27, 21) in a position during a separating movement of the container sections (1, 2). Furthermore, retaining means (15, 16) are provided for ensuring that the valve members (22, 19) do not engage the valve seats (27, 21) in the coupled state of the container sections (1, 2).

TECHNICAL FIELD

The invention relates to a container for receiving and separating afluid, preferably blood plasma, into its ingredients, where saidcontainer comprises two sealingly coupled sections.

BACKGROUND ART

It is known inter alia from U.S. Pat. No. 4,714,457 to utilize theplasma fraction in blood for the preparation of so-called tissue glue.According to the publication the coagulation factors, such asfibrinogen, fibronectin, factor VIII, and factor XIII are precipitatedfrom the plasma fraction. These coagulation factors are precipitated forinstance by cryoprecipitation or by means of a precipitation-promotingagent such as ethanol. The precipitated precipitate includes mainlyfibrinogen and is used as tissue glue, such as in connection withoperation wounds, by the addition of a suitable enzyme, such asthrombin. Like in nature, the fibrinogen and thrombin form togetherfibrin, which is an insoluble network of fibre-like materialconstituting a kind of tissue glue interconnecting the wound surfacesduring a healing process. On account of the latter effect, a concentrateof coagulation factors containing mainly fibrinogen turned out topossess a favourable effect on the healing process after an operation.For short, the concentrate of coagulation factors is below referred toas fibrinogen, as said fibrinogen is the main ingredient thereof.

Several methods are today used for separating plasma from blood. Theseparating process can be performed by means of filters or centrifugingtechniques or by way of combinations thereof. The methods are usuallyknown as "plasmapheresis". The methods have been developed because it isoften sufficient to give the patients a plasma transfusion, whereby itis unnecessary also to remove slowly regenerating blood cells from thedonor.

The precipitation of fibrinogen from plasma has previously beenperformed in closed bag systems. The precipitation into such bags (bloodbags) necessitated production of particular means for securing the bagsin a for centrifugal bowl, in which the centrifuging is to be performed.In addition, it is difficult to separate the fibrinogen from the plasmain a reliable manner. The flexibility of the blood bags often results inthe viscous fibrinogen loosening from the bag and mixing with theremaining plasma in the bag, whereby the concentration is substantiallyreduced. The latter problems have had the effect that these methods arenot used by way of routine today.

DESCRIPTION OF THE INVENTION

The container according to the present invention is characterised inthat at least one container section and the adjacent portion of theother container section are made substantially of solid material, thatthe two container sections can be separated, whereby the sections remainsealingly connected during the separating movement away from oneanother, that the container sections comprise their respective chamberfor receiving their respective fluid ingredient, that the chambers areinterconnected through a connecting channel defined by mutually abuttingportions of each container section, that a valve seat is shaped at eachend of the connecting channel for each valve member for a sealingclosing of the chambers in the separated state of the containersections, that the valve members comprise mutually abutting projectionsensuring a distance between the valve members exceeding the distancebetween the associated valve seats in the coupled state of the containersections, but being smaller than the distance between the associatedvalve seats in a position during the separating movement of thecontainer sections, and that retaining means are provided for ensuringthat the valve members do not engage the valve seats in the coupledstate of the container sections.

The resulting container is well-suited for use during the precipitationof fibrinogen from plasma. In addition, the container allows a sterilestoring of the two separated fractions in their respective separatecontainer section. In this manner, the fibrinogen can be storedseparately in a refrigerator until it is heated to liquid stateimmediately before its use and transferred to a syringe so as to be usedas tissue glue. The suitability of the container is partly due to thefact that one container section is made of solid material, whereby thefibrinogen can be precipitated on a solid bottom, and partly due to thefact that the container sections can be separated and are automaticallyclosed during the separating movement, whereby the plasma and thefibrinogen are easily placed in their respective container section. Asthe distance between the valve members is smaller than the distancebetween the valve seats in a position during the separating movement ofthe container sections, the valve members close the openings into eachcontainer section before said container sections are completelyseparated during the last step of the separating movement. In thismanner, the sealing closing of the container sections can be performedautomatically without rendering it possible to handle the container inan incorrect manner.

According to the invention the projections of the valve members maycomprise co-operating and releasable snapping means ensuring that thevalve members remain coupled together in the coupled state of thecontainer sections. In this manner, a predetermined resistance isensured against a separation of the valve members during the separatingmovement of the container sections in such a manner that the valvemembers are caused to engage their respective valve seats under apredetermined load, whereby said valve members can enter the engagementby way of friction and be retained in said engagement with the valveseats by the friction. In addition, one valve member can be supported ata distance from the associated valve seat by means of the other valvemember and retaining means associated therewith.

The retaining means may according to the invention advantageouslycomprise a retaining projection placed at least on one valve member,said retaining projection extending away from the other valve member andengaging by way of friction adjacent portions of the correspondingcontainer section.

The valve members may according to the invention be associated withtheir respective biased spring adapted to press said valve members intoa sealing engagement with the valve seats during the separation of thecontainer sections. In this manner, an additional pressing force isensured for the valve members against the valve seats during and afterthe separating procedure.

According to the invention the retaining projection on at least onevalve member may advantageously comprise a recess for a co-operation byway of friction with a projection on the wall of the correspondingcontainer section opposite the valve seat.

Moreover according to the invention the container sections may becoupled together by means of co-operating threads, whereby the couplingand separation of the container sections can be performed in aparticularly simple manner.

Furthermore according to the invention, means may preferably be providedfor feeding fluid into the container under sterile conditions and forremoving fluid ingredients also under sterile conditions from at leastone of the separated container sections through the wall thereof. As aresult it is possible to remove especially the fibrinogen from thecontainer section in question without opening the valve.

Finally according to the invention the opposing projections of the valvemembers may comprise a recess on one projection, said recesstelescopically receiving the other projection, and the snapping meansmay be formed by a circumferential rib placed on one projection andengaging a circumferential groove on the other projection with theresult that the valve members are retained relative to one another in aparticularly simple manner.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention is described in greater detail below with reference to theaccompanying drawing, in which

FIG. 1 is a side and substantially sectional view of a containeraccording to the invention,

FIG. 2 illustrates on a larger scale the lower portion of the containerof FIG. 1,

FIG. 3 corresponds to FIG. 2, but in a position during the separatingmovement of the two sections of the container,

FIG. 4 corresponds to FIG. 2, but illustrating the two completelyseparated container sections, and

FIG. 5 is a diagrammatic, sectional view of another embodiment of acontainer according to the invention.

BEST MODE FOR CARRYING OUT THE INVENTION

The container of FIGS. 1 to 4 comprises two container sectionsdesignated by the general reference numerals 1 and 2. The uppercontainer section 1 comprises a conventional bottomless blood bag 3, cf.FIG. 1, welded at the lower open end 4 between a rotationallysymmetrical mouth portion 5 abutting the inner side of the blood bag 3and a sleeve-shaped tube portion 6 abutting the outer side of said bloodbag. The mouth portion 5 continues through a shoulder portion 7 into atubular portion 8 provided with a thread 9 on the outside.

The lower second container section 2 is screwed on the thread 9 of themouth portion 5, cf. the drawing. The entire lower container section 2is rotationally symmetrically shaped and comprises a tubular portion 10provided with an internal thread 11. The internal thread 11 engages thethread 9 on the upper container section. The tubular portion 10continues through a shoulder portion 12 into a cylindrical portion 13.The free end of the cylindrical portion is closed by means of a bottommember 14. The bottom member 14 comprises a disk with a circumferentialflange 15' abutting the inner side of the cylindrical portion 13. Thebottom member comprises furthermore a central, rotationally symmetricalprojection 15 projecting into the interior of the second containersection 2. A first valve member 16 is retained on the latter projectionby way of friction, said valve member also being rotationallysymmetrically shaped.

The first valve member 16 comprises a tubular portion 17 engaging theprojection 15 on the bottom member 14. The cylindrical portion continuesinto a conical portion 18 in turn continuing into a comparativelynarrower cylindrical portion 19. The cylindrical portion 19 forms aprojection of the valve member 16. The projection 19 is narrower thanthe cylindrical portion 17 engaging the projection 15 of the bottommember 14. Along the transition area between the broad cylindricalportion 17 and the conical portion 18, the first valve member 16 isadapted to co-operate sealingly with the adjacent inner side of thethreaded tubular portion 10 on the lower container section 2. Thus thearea in question of the inner side of the tubular portion 10 forms avalve seat 21 for the first valve member. The valve seat 21 and thevalve member 16 are besides formed in such a manner that they co-operatewith one another by way of friction.

A second valve member 22 is telescopically received on the narrowprojection 19 of the first valve member 16. Thus the second valve member22 comprises a cylindrical projection 23 surrounding the projection 19on the first valve member 16. Internally, the cylindrical projection 23comprises a transverse wall 24. Like the first valve member 16, thesecond valve member 22 comprises a conical portion 25 expanding in adirection away from the projection 23 at the end farthest from the valvemember 16 and ending at a cylindrical portion 26. The transition areabetween the conical portion 25 and the cylindrical portion 26 is adaptedto co-operate in a sealing manner with the inner side of the mouthportion 5 of the upper container section 1 on the inner side of thethreaded tubular portion 8 of said mouth portion. The portion inquestion of the mouth portion forms thus a valve seat 27 for the secondvalve member 22. The valve seat 27 and the valve member 22 are adaptedto co-operate with one another by way of friction.

The end of the second valve member 22 facing the interior of the bloodbag 3 is closed by means of a conical cap 28 glued thereon.

As illustrated in the drawing, the telescopically cooperatingprojections 19 and 23, respectively, of the two valve members 16 and 22are of such a length that the two valve members 16 and 22 in theposition shown in FIGS. 1 and 2 are retained inside their respectivecontainer section 2 and 1 at a distance from the associated valve seats21 and 27, said valve members in FIGS. 1 and 2 being supported by theprojection 15 on the lower container section 2. As a result, an openconnection exists between the interiors of the two container sections 1and 2. Thus an open connection exists between a first chamber 29 insidethe upper container section 1 and a chamber 30 inside the lowercontainer section 2 through a connecting channel 31. The connectingchannel 31 is defined by the tubular portions 8 and 10, respectively, ofthe two container sections 1 and 2. As clearly illustrated in FIG. 4,the projection 19 on the first valve member 16 comprises acircumferential rib 32. Correspondingly, the projection 23 on the secondvalve member 22 comprises on the inner side a circumferential groove 33.The rib 32 and the groove 33 are adapted to snap-engage one another insuch a manner that the second valve member 22 remains positioned on thefirst valve member 16 in the position of FIG. 1 and is only released bya predetermined force in the axial direction thereof.

The distance between the two valve members 16 and 22 in the engagingposition of the rib 32 and the groove 33 is of such a size, cf. FIG. 3,that the valve members 16 and 22 engage their associated valve seats 21and 27, respectively, when the two container sections 1 and 2 have beenpartially unscrewed from one another, but are still engaging one anotherthrough their threads 9 and 11. As also illustrated in FIG. 3, the firstvalve member 16 is partially disengaging the projection 15 on the bottomportion 14 of the lower container section 2 in the position in which thevalve members 16 and 22 have fully engaged their valve seats 21 and 27.The engagement of the valve members 16 and 22 by means of the rib 32 andthe groove 33 has the effect that the valve members 16 and 22 remaincoupled together until they have been pulled into position relative totheir valve seats 21 and 27.

A continued unscrewing of the two container sections 1 and 2 relative toone another has the result that the two valve members 16 and 22 arepulled out of their engagement, cf. FIG. 4, and left sealingly engagingtheir respective valve seats 21 and 27.

As illustrated in the drawing, the first container section comprises atubing 34 for the feeding of plasma to the first container section 1.The container section comprises furthermore a tubing 35 allowing feedingunder sterile conditions through a conventional filter of an agent, suchas alcohol, for instance ethanol, for an acceleration of theprecipitation of a concentrate of coagulation factors in the container.

A rubber membrane 37 is furthermore provided within the shoulder portion12 on the second container section, said rubber membrane allowingexsuction of concentrate from the second container section 2 by means ofa syringe.

Beyond assisting in fastening the blood bag 3 on the mouth portion 5 ofthe upper container section 1, the outer sleeve-shaped tube portion 6serves also to provide the container with a pleasant appearance, saidtube portion 6 abutting the broad cylindrical portion 13 on the secondcontainer section 2 when the two container sections are screwed tightlytogether.

When the container according to the invention is used, plasma is filledtherein through the tubing 14. After addition of suitable agents foraccelerating the precipitation of coagulation factors, the precipitationprocess is initiated in a conventionally known manner, such as by way ofcryoprecipitation. Subsequently, the container is subjected to acentrifuging in such a manner that the very viscous concentrate isplaced in the second chamber 30 of the container inside the secondcontainer section 2. When the concentrate has been collected in thesecond container section 2, the container is turned in such a mannerthat the container section 1 with the blood bag 3 faces downwards. As aresult, the blood plasma flows into the blood bag 3 while theconcentrate of fibrinogen or coagulation factors remain in the containersection 2 now being the upper section. Then the two container sections 1and 2 are separated by being unscrewed from one another. As the twocontainer sections gradually reach the position shown in FIG. 3 duringtheir separating movement, the two valve members 16 and 22 are pulledinto a tight engagement with their respective valve seats 21 and 27. Acontinued unscrewing during the last step of the mutual separatingmovement of the two container sections causes the two valve members 16and 22 to be pulled out of their engagement. Finally, the two containersections 1 and 2 reach the completely separated state shown in FIG. 4,said state allowing the sections to be handled separately according todesire. The container section 2 containing the concentrate can be placedin an refrigerator until the concentrate is to be used. When theconcentrate is to be used, it is heated until it is sufficiently liquidfor being sucked out through the rubber membrane 37.

FIG. 5 is a diagrammatic view of a second embodiment of the invention,where parts corresponding to the embodiment of FIGS. 1 to 4 have beenprovided with the same reference numerals. The container of FIG. 5comprises also two container sections 1 and 2. These container sections1 and 2 are screwed together by means of a short thread. Therefore, asterile-closing membrane 40 is provided about the connection place, saidmembrane being diagrammatically indicated. The membrane 40 is brokenwhen the two container sections 1 and 2 are pulled a short distanceapart after having been unscrewed from one another. Each containersection 1 and 2 comprises a valve member 19 and 22 co-operating withtheir respective valve seat 21 and 27. Both valve members 19 and 22comprise projections 41 and 42 facing away from their valve seats, saidprojections being received in their respective guide tubing 43 and 44,respectively. A spring 45 and 46 is arranged about each projection 41and 42, said springs biasing the valve members 19 and 22 forwardstowards their valve seats 21 and 27. The valve members 19 and 22comprise furthermore projections 47 and 48 projecting forwards towardsone another and abutting one another in the position shown in FIG. 5 soas to keep the valve members 19 and 22 in contact with the ends of theguide tubings 43 and 44 at a distance from the valve seats 21 and 27.The separation of the two container sections 1 and 2 activates thesprings 45 and 46 to press the valve members against their respectivevalve seats 21 and 27, the two abutting projections 47 and 48 being ofsuch a length that the valve seats engage one another before themembrane 40 is broken.

The embodiment of the container shown in FIG. 5 is used in the samemanner as stated above.

The container according to the invention is easily produced frominjection moulded parts, and as far as the embodiment of FIGS. 1 to 4 isconcerned the two valve members 16 and 22 are assembled before the bloodbag 3 is glued onto the mouth portion 5. Before the second valve member22 is secured to the first valve member 16, said first valve member ismounted on the projection 15 on the bottom member 14, which issubsequently glued onto the second container section 2. The blood bag 3is, as mentioned, fastened by way of gluing, but it can also be fastenedby way of welding. Both the second container section 2 and the valvemembers 16 and 22 as well as the mouth portion 5 of the first containersection 1 and the sleeve-shaped tube portion 6 are made of a solidplastic material, which may be of any suitable nature, such as polyvinylchloride.

The invention has been described with reference to preferredembodiments. Many modifications may, however, be carried out withoutthereby deviating from the scope of the invention. The container ofFIGS. 1 to 4 may for instance be of another shape than the rotationallysymmetrical shape. Suitable sealing means may furthermore be provided inorder to ensure the necessary sealing. The described container ispreferably intended for use in connection with blood plasma, but it may,of course, also be used for other fluids with ingredients available instates allowing the described separation.

I claim:
 1. A container for receiving and separating a fluid into two ormore ingredient fractions, comprising:a first container section and asecond container section, said container sections being movable relativeto one another so that they can selectively be fully coupled, partiallycoupled, or separated from one another; each of said container sectionsincluding a fluid receiving chamber and an abutting portion cooperatingwith the other container section when the container sections are fullyor partially coupled; said container sections adapted to be selectivelysealingly engaged when fully or partially coupled, such that aconnecting channel between said chambers is formed comprising saidabutting portions; at least one of said container sections and a portionof the other container section being made substantially of rigidmaterial, the rigid container section and the rigid portion of the othercontainer section being adjacent one another when the container sectionsare fully coupled; said container sections further comprising respectivevalve seats proximate said connecting channel and respective valvemembers; said valve members comprising portions adapted to cooperatewith said valve seats to selectively sealingly close said fluidreceiving chambers when said container sections are separated; saidvalve members further comprising projections which are mutually abuttingat least when said container sections are fully coupled; saidprojections dimensioned to maintain the distance between saidcooperating portions of said valve members at a value which is greaterthan the distance between said valve seats when said container sectionsare fully coupled, and to allow said cooperating portions of said valvemembers to engage said valve seats to close said fluid receivingchambers before said container sections are separated; and retainingmeans for ensuring that said valve members do not engage said valveseats when said container sections are fully coupled.
 2. The containerof claim 1 wherein said projections include cooperating snaps releasablyconnecting said projections when said container sections are fullycoupled.
 3. The container of claim 2 wherein one of said projectionscomprises a bore for receiving a cooperating portion of the otherprojection; andwherein said cooperating snaps comprise a rib associatedwith one of said projections, and a cooperating circumferential recessassociated with the other of said projections.
 4. The container of claim1 wherein said retaining means comprises a retainer on at least one ofsaid valve members, said retainer extending away from the other valvemember and frictionally engaging an adjacent portion of thecorresponding container section.
 5. The container of claim 4 whereinsaid retainer comprises a recess for frictionally receiving saidadjacent portion, and wherein said adjacent portion comprises acooperating projection received within said recess.
 6. The container ofclaim 1 wherein at least one of said valve members further comprises abiasing spring, said biasing spring urging said valve member toward thecorresponding valve seat.
 7. The container of claim 1 wherein saidabutting portions comprise cooperating threads.
 8. The container ofclaim 1 further comprising means for feeding fluid into at least one ofsaid container sections under sterile conditions; andmeans for removingat least an ingredient fraction of said fluid from at least one of saidcontainer sections through the wall of said container section when thecontainer sections are separated.